The US Food and Drug Administration (FDA) has issued a draft guidance entitled ‘Computer Software Assurance for Production and Quality Management System Software’. Aimed at medical device manufacturers, this document:
The document can be found here: https://www.fda.gov/media/188844/download
The Medicines and Healthcare products Regulatory Agency (MHRA) has launched a consultation on indefinite recognition of CE-marked medical devices. This is aimed at protecting patient access and ensuring the continued supply of safe and effective medical technologies.
Around 90% of medical devices currently used in Great Britain are CE marked. The proposals for indefinite recognition would ensure consistent long-term supply to support the health system. The consultation seeks feedback on the proposals to extend arrangements put in place in 2023 to recognise CE marked devices and forms part of the MHRA’s wider programme of regulatory reform of medical devices, designed to be risk-proportionate, pro-innovation and patient-focused.
The document can be accessed here: https://www.gov.uk/government/consultations/medical-devices-regulations-targeted-consultation-on-the-indefinite-recognition-of-ce-marked-devices
The UK Health Security Agency (UKHSA) is urging the public not to use four specified non-sterile alcohol-free wipe products due to the risk of infection associated with their use. There have been 59 confirmed cases of Burkholderia stabilis associated with some non-sterile alcohol-free wipe products, identified in an outbreak in the United Kingdom from January 2018 to 3 February 2026. The wipes in question are:
A small number of cases continue to be detected.
For details see: https://www.gov.uk/guidance/burkholderia-stabilis-infections-associated-with-non-sterile-alcohol-free-wipes-ongoing-risk-to-patients
Amendments to the EU Commission Implementing Regulation (CIR) 520/2012 came into effect from 12 February 2026. While the UK operates an independent regulatory system, these changes have practical implications for some UK-authorised products, particularly in relation to pharmacovigilance (PV) requirements.
All UK authorised products are granted authorisations by the MHRA and are subject to PV requirements set out in Part 11 of the Human Medicines Regulations (HMR) 2012. However, additional PV requirements apply depending on the category of product.
For details, see: https://www.gov.uk/government/publications/updates-to-cir-5202012-information-for-uk-marketing-authorisation-holders
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) has issued ‘ICH E20 adaptive designs for clinical trials – Scientific Guideline’. This document provides guidance on confirmatory clinical trials planned with an adaptive design within the context of its overall development programme, allowing pre-specified modifications of the trial design based on an interim analysis of the on-going trial.
In addition, the guideline discusses opportunities for the application of Bayesian methodology. Input is sought whether there are further examples where Bayesian methodology can be employed in a way that it can be discussed within the clinical context of use.
To access see: https://www.ema.europa.eu/en/documents/scientific-guideline/ich-e20-guideline-adaptive-designs-clinical-trials-step-2b_en.pdf
ICH has issued a guideline titled ‘ICH M15 guideline on general principles for Model-Informed Drug Development - Scientific guideline’.
In the rapidly evolving landscape of drug development, Model-Informed Drug Development (MIDD) evidence is playing an increasingly crucial role in guiding decisions made by drug developers, regulatory authorities, and other key stakeholders.
To streamline the assessment of this valuable evidence, the guideline seeks to facilitate a comprehensive, multidisciplinary approach.
Good Pharmacovigilance Practices (GVP) are a set of measures drawn up to facilitate the performance of pharmacovigilance in the European Union (EU).
European Medicines Agency (EMA) has issued a related document titled ‘Guidelines on good pharmacovigilance practices (GVP): Introductory cover note, last updated with final considerations on pregnant and breastfeeding women and their children exposed in utero or via breastmilk’.
Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S) and the EMA are considering extending the scope of Annex 15 to active substances. For this, a concept paper has been issued.
This includes a set of recommendations aimed at preventing the presence of unexpected impurities in human medicines.
The EMA has drafted a document in relation to veterinary medicine, titled ‘Guideline for the evaluation of efficacy of ectoparasiticides - general requirements’.
This guideline provides general guidance on the data requirements, the design and conduct of preclinical studies and clinical trials to support efficacy for an ectoparasiticidal veterinary medicinal product.
Appropriate methods and approaches to demonstrate efficacy against the target ectoparasites are presented in the document.
Neuromuscular Junction (NMJ) disorders represent a heterogeneous group of acquired or congenital disorders characterised by an impaired signal transmission between motor neurons and skeletal muscle fibres.
The most common NMJ disorder is Myasthenia Gravis (MG), a chronic disorder characterised by fluctuating weakness and fatigability of skeletal muscles due to a humoral immune response targeting key components of the post-synaptic membrane.
The EMA has issued new draft guidance for clinical investigations: https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-need-guideline-clinical-investigation-medicinal-products-treatment-myasthenia-gravis_en.pdf
EMA has issued guidance aimed at supporting applicants in completing the 'Precise scope and background for a change, and justification for grouping, work-sharing and classification for unforeseen changes (if applicable)' section of the Application Form for Type I and Type II variations.
The FDA has issued a draft guidance titled ‘Certification Process for Designated Medical Gases’. This applies to:
To access, see: https://www.fda.gov/media/191040/download
The FDA has produced a recommendation to industry regarding cybersecurity device design, labelling, and the documentation be included in premarket submissions for devices with cybersecurity risk.
The guidance is designed to ensure that medical devices are resilient to cybersecurity threats. It can be found here: https://www.fda.gov/media/119933/download
In a related area, the FDA has issued guidance to provide recommendations on computer software assurance for computers and automated data processing systems used as part of medical device production or the quality management system.
This guidance can be found here: https://www.fda.gov/media/188844/download
MHRA has revised its guidance for reporting, investigating and recalling suspected defective medicinal products to the Defective Medicines Report Centre (DMRC).
The document can be accessed here: https://assets.publishing.service.gov.uk/media/698f286b43eb912f2e15b3fd/DMRC_Guide-to-Defective-Medicinal_Products-Feb2026.pdf
The European Pharmacopeia, in edition 12.3, is updating the monographs for Water for Injections (0169) and Purified Water (0008). This is for TOC and conductivity updates.
The updates can be accessed through EDQM (requires subscription).
The European Pharmacopeia (Ph. Eur.) has a new chapter (5.38) from edition 12.3 onwards. This is titled ‘Quality of data’ and it will cross refer to digital/technological transformation (5.21. Chemometric methods applied to analytical data, 5.28. Multivariate statistical process control and 5.33. Design of Experiments) and to the data analysis processes outlined in 5.24. Chemical Imaging and 5.25. Process analytical technology.
The updates can be accessed through EDQM (requires subscription).
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